Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03039764
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 51.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. Also, what impact does this have on quality of life.

Condition or Disease	Intervention/Treatment	Phase
Stroke Syndrome; Hemiplegia	Device: Rapael	N/A

Detailed Description

The American Stroke Association states that stroke is 5th leading cause of death in the United States and one of the leading causes of disability and loss of motor function. Approximately 80% of stroke survivors have upper extremity limitations where the distal upper extremity motor function is severely affected and is the last body part to recover. Restoration of arm function is essential to regaining activities of daily living (ADL) such as holding objects like utensils, turning a doorknob, writing or telephone use. Literature search shows that intensive and repetitive training may be necessary to modify neural organization and recover functional motor skills. Along with traditional rehabilitation methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based rehabilitation is more intensive, of longer duration and more repetitive. Using VR rehabilitation, repetitive dull exercises can turn into a more challenging and motivating tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of the rehabilitation progress.

The investigators propose a study comparing conventional occupational services versus virtual reality-based rehabilitation intervention for participants during acute phase of stroke in the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will see a significant increase in the overall motor function, shorter hospital course and improved quality of life for the participants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy
• Actual Study Start Date: Apr 30, 2018
• Actual Primary Completion Date: Aug 19, 2021
• Anticipated Study Completion Date: Aug 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard occupational therapy This group will receiving standard occupational therapy for the treatment of acute stroke.
Experimental: SOT plus VR Rapael This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.	Device: Rapael; This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.

Outcome Measures

Primary Outcome Measures

1. Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test [3 Months]

   Scores on the Wolf Motor Function test measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.

Secondary Outcome Measures

1. Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire [3 Months]

   Scores of Michigan Hand Outcome Questionnaire measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Minimum age of 18 years' old

• Unilateral upper extremity functional deficits after stroke

• First ever clinical diagnosis of stroke in the dominant hemisphere

• Diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand

Exclusion Criteria:

• Age less than 18 years' old

• Cognitive impairment resulting in inability to participate

• Severe aphasia resulting in inability to communicate to give consent or participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burke rehabilitation Hospital	White Plains	New York	United States	10605

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03039764
• Other Study ID Numbers: 2016-6572
• First Posted: Feb 1, 2017
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Stroke; Hemiplegia

Study Results

No Results Posted as of May 10, 2022